Dexrazoxane Injectable Solution

Brand(s)
Zinecard
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-04-25)
Oldest Current Product
1995-05-26
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\DEXRAZOXANE
FDAOB
INJECTION\INJECTION\DEXRAZOXANE HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DEXRAZOXANE HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DEXRAZOXANE

product(s) by strength(s)

dexrazoxane 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000138717ZinecardNDAPharmacia And Upjohn Company1995-05-26DEXRAZOXANE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA020212f68a34ae-e17e-45b3-8c8e-8d7194b2124a

generic product(s)(s)

#idcategorylabelerfirst marketedapplicationspl
1674570207ANDAMylan Institutional Llc2011-11-18ANDA20075277702d60-d1ea-4e4c-a837-aaa813b66064
2674570208ANDAMylan Institutional Llc2011-11-18ANDA20075277702d60-d1ea-4e4c-a837-aaa813b66064

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA076068DEXRAZOXANE HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2004-09-28ANDA076068_001, ANDA076068_002
2ANDA200752DEXRAZOXANE HYDROCHLORIDEMYLAN INSTITUTIONAL LLC2011-10-19ANDA200752_001, ANDA200752_002
3NDA020212ZINECARDPHARMACIA AND UPJOHN CO1995-05-26NDA020212_001, NDA020212_002
4NDA022025TOTECTBIOCODEX INC2007-09-06p6727253, TREATMENT OF EXTRAVASATION RESULTING FROM IV ANTHRACYCLINE CHEMOTHERAPYORPHAN DRUG EXCLUSIVITY [2014-09-06]NDA022025_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076068_001RXDEXRAZOXANE HYDROCHLORIDE (EQ 250MG BASE/VIAL)INJECTIONFalseAP2004-09-28DEXRAZOXANE HYDROCHLORIDE
2ANDA076068_002RXDEXRAZOXANE HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalseAP2004-09-28DEXRAZOXANE HYDROCHLORIDE
3ANDA200752_001RXDEXRAZOXANE HYDROCHLORIDE (EQ 250MG BASE/VIAL)INJECTIONFalseAP2011-10-19DEXRAZOXANE HYDROCHLORIDE
4ANDA200752_002RXDEXRAZOXANE HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalseAP2011-10-19DEXRAZOXANE HYDROCHLORIDE
5NDA020212_001RXDEXRAZOXANE HYDROCHLORIDE (EQ 250MG BASE/VIAL)INJECTIONTrueAP1995-05-26ZINECARD
6NDA020212_002RXDEXRAZOXANE HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONTrueAP1995-05-26ZINECARD
7NDA022025_001RXDEXRAZOXANE HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONTrue2007-09-06TOTECT

patent(s)

#idexpiration dateapplication(s)
1p6727253 (view patent)2020-03-13NDA022025

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
177702d60-d1ea-4e4c-a837-aaa813b66064 (view SPL)These highlights do not include all the information needed to use dexrazoxane for injection safely and effectively. See full prescribing information for dexrazoxane for injection. DEXRAZOXANE for injection, for intravenous use onlyInitial U.S. Approval: 1995prescriptionHuman PrescriptionMylan Institutional Llc2015-05-125674570207, 674570208
2f68a34ae-e17e-45b3-8c8e-8d7194b2124a (view SPL)These highlights do not include all the information needed to use ZINECARD safely and effectively. See full prescribing information for ZINECARD.ZINECARD (dexrazoxane) for injectionInitial U.S. Approval: 1995prescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, MANUFACTURE2014-04-2510000138717, 000138727

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII